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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantDEPUY, INC.
PMA NumberP070026
Supplement NumberS003
Date Received07/18/2011
Decision Date09/16/2011
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the trio-lock bps (bone preserving hip stem) and 28 mm ceramic femoral heads with a 12/14 taper and +1. 5 mm, +5 mm, and 8. 5 mm offset as compatible modular components to the system, and minor labeling changes to the device package insert and surgical technique. The device, as modified, will be marketed under the trade name depuy ceramax ceramic total hip system and is indicated for noncemented use in skeletally mature individuals undergoing primary total hip replacement surgery for rehabilitation of hips damaged as a result of noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and post traumatic arthritis.
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